Stephen Sidney Md British Medical Journal Comparing Cannabis With Tobacco Again

(Jan. 1, 1997 to June 30, 2005)

• Background
• Cause of Death Categories & Definitions
• FDA Disclaimer of Data
• Summary of Deaths by Drug Classification
• Deaths from Marijuana & 17 FDA-Approved Drugs
• Sources & Disagreement on Marijuana Deaths
• Full Text of All 17 FDA "Adverse Upshot" Reports

I. Background

Much of the medical marijuana discussion has focused on the safety of marijuana compared to the safety of FDA-approved drugs. On June 24, 2005 ProCon.org sent a Freedom of Information Act (FOIA) request to the US Food and Drug Administration (FDA) to discover the number of deaths caused by marijuana compared to the number of deaths caused by 17 FDA-canonical drugs. Twelve of these FDA-canonical drugs were called because they are commonly prescribed in place of medical marijuana, while the remaining 5 FDA-canonical drugs were randomly selected because they are widely used and recognized by the general public.

We chose Jan. one, 1997 every bit our starting engagement as it is the beginning of the first yr following the Nov. 1996 approving of the first land medical marijuana laws (such as California'south Suggestion 215). The FDA reports we read from Sep. thirteen, 2005 to Oct. 14, 2005 included drug deaths "to present", which was the date each written report was compiled for our asking. We cut off the counting as of June thirty, 2005 to provide a uniform end-date to the various reports.

On Aug. 25, 2005 the FDA sent us 12 CDs and five printed reports containing copies of their Agin Event Reporting Organisation (AERS) study on each drug requested. These reports included all adverse events reported to the FDA, simply a portion of which included deaths. We manually counted the number of deaths reported on each drug from the FDA-supplied information.

A review of the FDA Agin Events reports also revealed some deaths where marijuana was at least a concomitant drug (a drug also used at the time of decease) in some cases. On Oct. fourteen, 2005 nosotros used the Freedom of Data Act to request a copy of the adverse events reported deaths for marijuana, cannabis, and cannabinoids. Nosotros received those reports on Aug. iii, 2006 in the grade of three additional CDs. The FDA listed over 150 deaths on more than one report (aka double counted them), however, to ensure accuracy, we removed duplicates from our terminal count. All the FDA adverse events reports that we received can exist seen in total at the bottom of this page.

II. Crusade of Expiry Categories & Definitions

The FDA AERS reports rely on health professionals to find an "adverse event" and attribute that event to the drug, and then to voluntarily written report that result to either the FDA or the drug manufacturer. The drug house, by law, must report that result to the FDA. The FDA states "ninety percent of the FDA's reports are received from drug manufacturers" on folio i of its "Agin Event Reporting Arrangement (AERS) Brief Description with Caveats of System." (PDF 2.7 MB)

Select instructions on how to report agin events, as per the FDA's AERS Form Instructions are provided below:

• Adverse Event: Any incident where the use of a medication (drug or biologic, including HCT/P), at whatever dose, a medical device (including in vitro diagnostics) or a special nutritional product (due east.g., dietary supplement, infant formula or medical food) is suspected to take resulted in an adverse effect in a patient.
• Death: Check but if you suspect that the death was an outcome of the agin upshot, and include the engagement if known. Practice non check if:
  • The patient died while using a medical production, just in that location was no suspected association between the death and
  • A fetus is aborted because of a congenital anomaly (birth defect), or is miscarried

• Suspect Production(south): A suspect production is one that you doubtable is associated with the adverse event.
  Upwardly to ii (ii) suspect products may be reported on one course (#1=commencement suspect product, #2=2nd suspect product). Attach an boosted form if there were more than two suspect products associated with the reported adverse event.
• To report: it is not necessary to be certain of a crusade/effect relationship between the adverse result and the use of the medical production(southward) in question. Suspicion of an association is sufficient reason to report. Submission of a report does not institute an admission that medical personnel or the product acquired or contributed to the issue.

Three. FDA Disclaimer of Data

Included in the 15 CDs and v printed reports from the FDA was the following disclosure:

"The information contained in the reports has not been scientifically or otherwise verified. For any given report there is no certainty that the suspected drug caused the reaction. This is considering physicians are encouraged to report suspected reactions. The event may have been related to the underlying disease for which the drug was given to concurrent drugs existence taken or may take occurred past take a chance at the same time the suspected drug was taken.

Numbers from these information must be carefully interpreted as reported rates and not occurrence rates. Truthful incidence rates cannot be determined from this database. Comparisons of drugs cannot be fabricated from these data."

July xviii, 20/05 – FDA Office of Pharmacoepidemiology and Statistical Science, "Agin Event Reporting System (AERS) Brief Description with Caveats of Organisation"

[Editor'south Note – ProCon.org makes no claim that the information below reflects occurrence rates. The data is presented for our readers' benefit who may experience that the relative comparisons have value. ProCon.org attempted to detect the total number of users of each of these drugs by contacting the FDA, pharmaceutical trade organizations, and the actual drug manufacturers. We either did not receive a response or were told the information was proprietary or otherwise unavailable]

IV. Summary of Deaths by Drug Classification

DRUG Nomenclature		Specific Drugs per Category	Principal Suspect of the Death	Secondary Suspect (Contributing to death)	Full Deaths Reported 1/1/97 – 6/thirty/05
A. MARIJUANA too known as: Cannabis sativa L		Marijuana Cannabis Cannabinoids	0	279	279
B. ANTI-EMETICS (used to treat vomiting)		Compazine Reglan Marinol Zofran Anzemet Kytril Tigan	196	429	625
C. ANTI-SPASMODICS (used to treat muscle spasms)		Baclofen Zanaflex	118	56	174
D. ANTI-PSYCHOTICS (used to treat psychosis)		Haldol Lithium Neurontin	one,593	702	2,295
E. OTHER Popular DRUGS (used to treat various conditions including Add together, low, narcolepsy, erectile dysfunction, and pain)		Ritalin Wellbutrin Adderall Viagra Vioxx*	eight,101	492	8,593
F. TOTALS of A-Eastward		Number of Drugs in Full	Principal Doubtable of the Decease	Secondary Suspect (Contributing to death)	Full Deaths Reported 1/one/97 – 6/30/05
TOTAL DEATHS FROM MARIJUANA		1	0	279	279
Total DEATHS FROM 17 FDA-Approved DRUGS		17	x,008	1,679	11,687

V. Chart of Deaths from Marijuana and 17 FDA-Approved Drugs

A. Marijuana
DRUG (Year Approved)		Primary Doubtable of the Decease	Secondary Doubtable (Contributing to death)	Full Deaths Reported ane/1/97 – half dozen/thirty/05
one.	Marijuana (not approved) likewise known equally: Cannabis sativa L	0	109	109
two.	Cannabis (not approved) also known as: Cannabis sativa L	0	78	78
3.	Cannabinoids (unclear if these mentions include non-plant cannabinoids)	0	92	92
Sub-Total – Anti-Emetics		0	279	279

FDA-Canonical Drugs Prescribed in Identify of Medical Marijuana B. Anti-Emetics
DRUG (Year Approved)		Principal Suspect of the Decease	Secondary Suspect (Contributing to death)	Total Deaths Reported i/1/97 – 6/thirty/05
ane.	Compazine (1980) also known every bit: Phenothiazine, prochlorperazine	15	30	45
ii.	Reglan (1980) as well known as: Metaclopramide, Paspertin, Primperan	37	278	315
iii.	Marinol (1985) also known as: Dronabinol	4	1	v
4.	Zofran (1991) also known as: Ondansetron hydrochloride	79	76	155
5.	Anzemet (1997) as well known as: Dolasetron mesylatee	22	5	27
6.	Kytril (1999) also known as: Granisetron hydrochloride	36	24	60
7.	Tigan (2001) also known every bit: Trimethobenzamide	3	15	18
Sub-Full – Anti-Emetics		196	429	625

C. Anti-Spasmodics
DRUG (Year Approved)		Primary Suspect of the Expiry	Secondary Doubtable (Contributing to death)	Full Deaths Reported 1/ane/97 – 6/30/05
i.	Baclofen (1967) also known equally: Lioresal, iv-amino-3-(4-chlorophenyl)-butanoic acid	72	33	105
ii.	Zanaflex (1996) also known equally: Tizanidine hydrochloride, Sirdalud, Ternelin	46	23	69
Sub-Total – Anti-Spasmodics		118	56	174

D. Anti-Psychotics
DRUG (Year Canonical)		Master Suspect of the Death	Secondary Doubtable (Contributing to death)	Total Deaths Reported 1/1/97 – six/30/05
1.	Haldol (1967) as well known as: Haloperidol, Haldol Decanoate, Serenace, Halomonth	450	267	717
2.	Lithium (1970) besides known equally: Lithium Carbonate, Eskalith, Lithobid, Lithonate, Teralithe, Lithane, Hypnorex, Limas, Lithionit, Quilonum	175	133	308
3.	Neurontin (1994) also known as: Gabapentin	968	302	one,270
Sub-Total – Anti-Psychotics		one,593	702	ii,295

E. Other Well-Known and Randomly Selected FDA-Approved Drugs
DRUG (Year Canonical)		Master Suspect of the Death	Secondary Suspect (Contributing to death)	Full Deaths Reported one/1/97 – six/xxx/05
1.	Ritalin (1955) also known as: Methylphenidate, Concerta, Medadate, Ritaline (used to care for ADD and ADHD)	121	53	174
two.	Wellbutrin (1997) also known every bit: Bupropion Hydrochloride, Zyban, Zyntabac, Amfebutamone (used to care for low & anxiety)	one,132	220	i,352
iii.	Adderall (1966) besides known as: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate USP, Amphetamine Sulfate USP (used to treat narcolepsy or to command hyperactivity in children)	54	12	66
4.	Viagra (1998) also known as: Sildenafil Citrate (used to care for erectile dysfunction)	2,254	40	2,294
5.	Vioxx* (1999) also known as: Rifecixub, Arofexx (used to treat osteoarthritis and hurting)	iv,540	167	4,707
Sub-Total – Other Pop Drugs		eight,101	492	eight,593

F. TOTALS of A-E		Principal Suspect	Secondary Suspect (Contributing to expiry)	Full Deaths Reported 1/1/97 – 6/30/05
TOTAL DEATHS FROM MARIJUANA		0	279	279
TOTAL DEATHS FROM 17 FDA-APPROVED DRUGS		ten,008	1,679	xi,687

*[Editor'southward Notation: Merck, the maker of Vioxx, publicly appear its voluntary withdrawal of Vioxx from the global market on September xxx, 2004. In 2005, informational panels in both the US and Canada encouraged the render of Vioxx to the market place, stating that Vioxx's benefits outweighed the risks for some patients. The FDA advisory console voted 17-fifteen to allow the drug to render to the market place despite being plant to increase middle risk. The vote in Canada was 12-1, and the Canadian panel noted that the cardiovascular risks from Vioxx seemed to be no worse than those from ibuprofen. Yet these recommendations, Merck has not returned Vioxx to the market as of July eight, 2009.]

VI. Sources & Disagreement on Marijuana Deaths

Has marijuana caused whatever deaths?
Full general Reference (not clearly pro or con) The Substance Abuse and Mental Wellness Services Administration'south (SAMHSA) 2003 report Mortality Data from the Drug Abuse Warning Network, 2001 (1.5 MB) stated:   "Marijuana is rarely the just drug involved in a drug corruption death. Thus… the proportion of marijuana-induced cases labeled equally 'Ane drug' (i.due east., marijuana just) will be naught or nearly zero." 2003 – Substance Corruption and Mental Health Services Assistants
PRO (Yes)	CON (No)
Thomas Geller, MD, Acquaintance Professor of Kid Neurology at the Saint Louis University Health Sciences Center, et al., wrote the post-obit in their Apr. iv, 2004 commodity titled "Cerebellar Infarction in Boyish Males Associated with Acute Marijuana Utilise," published in the journal Pediatrics:   "Each of the 3 cannabis-associated cases of cerebellar infarction was confirmed by biopsy (1 case) or necropsy (2 cases)… Brainstem compromise caused by cerebellar and cerebral edema led to death in the two fatal cases." April. 4, 2004 – Thomas Geller, Medico Liliana Bachs, MD, Senior Medical Officer at the Norwegian Found of Public Health, et al., wrote the following in their Dec. 27, 2001 commodity titled "Acute Cardiovascular Fatalities Following Cannabis Use," published in the journal Forensic Science International: "Cannabis is by and large considered to exist a drug with very low toxicity. In this newspaper, we report half-dozen cases where recent cannabis intake was associated with sudden and unexpected decease. An acute cardiovascular event was the probable cause of death. In all cases, cannabis intake was documented by blood analysis… Further investigation of clinical, toxicologial and epidemiological aspects are needed to enlighten causality between cannabis intake and astute cardiovascular events." Dec. 27, 2001 – Liliana Bachs, Physician [Editor's Note: Dr. Bachs clarified the findings from her Dec. 27, 2001 report reported to a higher place in a Nov. 28, 2005 e-mail to ProCon.org, equally quoted below. "Causality is a hard assessment in forensic toxicology. Information technology is often an 'exclusion diagnosis,' and and then it is in our cases. I'm therefore not sure nigh how to allocate those deaths. At the time I published that study I would probably non allocate [the cannabis] every bit principal causation considering it was not broadly accepted that [a death from cannabis] could occur at all. Today I see reports coming all the time that acknowledge cannabis cardiovascular risks, and the situation may be dissimilar."]	Stephen Sidney, MD, Associate Director for Clinical Enquiry at Kaiser Permanente, wrote the following in his Sep. 20, 2003 commodity titled "Comparing Cannabis with Tobacco — Once again," published in the British Medical Journal:   "No acute lethal overdoses of cannabis are known, in contrast to several of its illegal (for example, cocaine) and legal (for example, booze, aspirin, acetaminophen) counterparts… Although the utilize of cannabis is not harmless, the current knowledge base of operations does not back up the exclamation that information technology has any notable adverse public health impact in relation to mortality." Sep. 20, 2003 – Stephen Sidney, MD Joycelyn Elders, MD, old United states Surgeon General, wrote the following in her Mar. 26, 2004 editorial published in the Providence Journal: "Different many of the drugs we prescribe every day, marijuana has never been proven to crusade a fatal overdose." Mar. 26, 2004 – Joycelyn Elders, Doc

Vii. Full Text of All 20 FDA "Adverse Event" Reports

[Please note that some of these PDF files exceed v megabytes and may take several minutes to load]

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Source: https://medicalmarijuana.procon.org/deaths-from-marijuana-vs-fda-approved-drugs/

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